the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI After the PTCA Surgery.

Beijing Bozhiyin T&S

Status and phase: Unknown; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Normal Saline; Drug: Danhong Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT02158559

DH-140318-01

Details and patient eligibility

About

This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.

Full description

Research Topic.

• A randomized, double-blind, placebo-controlled, multi-center clinical trial of the effect of Danhong Injection on microcirculation in the treatment of patients with STEMI(ST- elevation myocardical infarction) after the PTCA surgery.

Research Purpose.

• This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.

Research design.

• A randomized, double-blind, placebo-controlled, multi-center clinical trial.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically definite or laboratory-supported diagnosis of STEMI ,with the indication of PTCA surgery.
• 18≤Age≤75;
• Agreed to join in the study and signed the inform consent form.

Exclusion criteria

• Cardiogenic shock , Killip III-IV degree , papillary muscle rupture , septal perforation , episodes of ventricular tachycardia and ventricular fibrillation after electrical cardioversion , temporary pacemaker implanted AVB III degree.
• Past history of PCI and CABG
• Acute or chronic infectious diseases(for example severe pneumonia);
• Recent history of hemorrhagic stroke(within six months)
• Combined with liver and kidney dysfunction;
• History of valvular heart disease;
• Congenital heart disease or Pulmonary hypertension;
• All kinds of history of cardiomyopathy;
• Bleeding and other thrombotic diseases;
• Severe anemia , thrombocytopenia , Other diseases of the blood system;
• Cancer , Autoimmune disease , All kinds of the patients who use the glucocorticoid and immunosuppressor;
• Menstrual period women, pregnant women and lactating women, pregnancy test positive or recent family planning.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

180 participants in 2 patient groups, including a placebo group

Danhong Injection

Experimental group

Description:

Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Treatment:

Drug: Danhong Injection

Normal Saline

Placebo Comparator group

Description:

0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Treatment:

Drug: Normal Saline